COVID-19 Update

Subunit Vaccines and the Fight Against COVID-19

Advances in technology are accelerating the development and manufacture of subunit vaccines.

The Impact of COVID-19 on Biologics Regulations

FDA’s response to COVID-19 may impact the biologics industry long term.

Guarding the Vaccine Cold Chain

Supply-chain visibility systems are proving their worth in the distribution of COVID-19 vaccines.

EMA’s CHMP Adopts Positive Opinion for Moderna COVID-19 Vaccine Use in Adolescents

July 23, 2021

The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.

Pfizer and BioNTech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses Within Africa

July 22, 2021

Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute Ltd to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.

SAHPRA Authorizes ImmunityBio to Proceed with Trial of T-Cell Vaccine as Booster Against COVID-19

July 16, 2021

ImmunityBio will proceed with a Phase I/II/III trial in South Africa of their dual-antigen T-cell vaccine as a boost in participants who were previously vaccinated against COVID-19.

PRAC Finds Link to Very Rare Cases of Myocarditis and Pericarditis with Comirnaty and Spikevax

July 15, 2021

EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.

EMA Advises Against Using Janssen’s COVID-19 Vaccine in People with Capillary Leak Syndrome

July 15, 2021

After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.

Moderna to Deliver 20 Million Doses of COVID-19 Vaccine to Argentina

July 13, 2021

Moderna announces supply agreement with the Argentina government for 20 million doses of Moderna’s COVID-19 vaccine.

FDA Clears Tevogen Bio’s IND Application for CTL COVID-19 Treatment

July 13, 2021

The IND for Tevogen Bio's TVGN-489, an allogeneic COVID-19-specific cytotoxic T lymphocyte, received rapid clearance from FDA.

Exscientia Receives Funding from COVID-19 Therapeutics Accelerator

July 08, 2021

Exscientia has been given funding from the COVID-19 Therapeutics Accelerator to accelerate the optimization of a new class of COVID-19 drugs created using its AI drug design platform.

EMA Approves Scale-Up Process for Janssen COVID-19 Vaccine

July 08, 2021

The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.

FDA Authorizes Additional Batch of the J&J COVID-19 Vaccine

July 07, 2021

An additional batch of the Janssen COVID-19 vaccine has been authorized by FDA under the Emergency Use Authorization.